Second Line ColoRectal Cancer Therapy in Combination With Combination of FOL- Folinic Acid(Leucovorin), F - Fluorouracil and OX - Oxaliplatin (FOLFOX) (HORIZON I)

Study Description

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Brief Summary:

The primary purpose of this study is to compare the efficacy of AZD2171 in combination with FOLFOX to the efficacy of bevacizumab in combination with FOLFOX, in the second-line treatment of patients with metastatic colorectal cancer

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer	Drug: AZD2171; Drug: 5-fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Bevacizumab	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	215 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Study to Compare the Efficacy of AZD2171 in Combination With 5-fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX) and the Efficacy of Bevacizumab in Combination With FOLFOX in the Second-line Treatment of Patients With Metastatic Colorectal Cancer
Study Start Date :	January 2006
Actual Primary Completion Date :	November 2007
Actual Study Completion Date :	October 2009

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: 1; Bevacizumab + FOLFOX	Drug: 5-fluorouracil; intravenous infusion; Other Name: 5-FU Drug: Leucovorin; intravenous infusion Drug: Oxaliplatin; intravenous infusion; Other Name: Eloxatin® Drug: Bevacizumab; intravenous infusion; Other Name: Avastin®
Experimental: 2; AZD2171 + FOLFOX	Drug: AZD2171; oral tablet; Other Names: cediranib; RECENTIN™ Drug: 5-fluorouracil; intravenous infusion; Other Name: 5-FU Drug: Leucovorin; intravenous infusion Drug: Oxaliplatin; intravenous infusion; Other Name: Eloxatin®

Outcome Measures

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Primary Outcome Measures :

1. Progression Free Survival [ Time Frame: Randomisation to data cut-off date of November 2007 ]
   Number of months from randomisation to the earlier date of objective progression or death

Secondary Outcome Measures :

1. Objective Response Rate [ Time Frame: Randomisation to data cut-off date of November 2007 ]

   Per RECIST Criteria (V1.0) and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= ##% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

   Confirmed Partial Response (PR) or Complete Response (CR) as defined by RECIST.

2. Overall Survival [ Time Frame: Randomisation to data cut-off date of 30 January 2009 ]
   Number of months from randomisation to the date of death from any cause
3. Quality Of Live(QOL) : Time to Worsening of Tissue Oxygen Index (TOI) [ Time Frame: Randomisation to data cut-off date of November 2007 ]
   Time when a sustained clinically important deterioration in TOI has been recorded: derived from the FACT-C questionnaires
4. QOL: Time to Worsening of Treatment-free Survival (TFS) [ Time Frame: Randomisation to data cut-off date of November 2007 ]
   Time when a sustained clinically important deterioration in TFS has been recorded: derived from the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaires
5. QOL: Time to Worsening of Clear Cell Sarcoma (CCS) [ Time Frame: Randomisation to data cut-off date of November 2007 ]
   Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires
6. QOL: Time to Worsening of FACT Colorectal Cancer Symptom Index(FCSI) [ Time Frame: Randomisation to data cut-off date of November 2007 ]
   Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Clinical diagnosis of colon or rectal cancer,
• Received prior systemic therapy for cancer,
• Cancer must have progressed during or after first treatment

Exclusion Criteria:

• Prior treatment with a VEGF inhibitor,
• Poorly controlled hypertension

Contacts and Locations

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Locations

Austria
Research Site
Innsbruck, Austria
Research Site
Wels, Austria
Research Site
Wien, Austria
Belgium
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Bonheiden, Belgium
Ressearch Site
Brussels, Belgium
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Edegem, Belgium
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Gent, Belgium
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Leuven, Belgium
Canada, Manitoba
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Winnipeg, Manitoba, Canada
Canada, New Brunswick
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Moncton, New Brunswick, Canada
Canada, Ontario
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Kingston, Ontario, Canada
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Ottawa, Ontario, Canada
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Sudbury, Ontario, Canada
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Toronto, Ontario, Canada
Canada, Quebec
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Montreal, Quebec, Canada
Czech Republic
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Chomutov, Czech Republic
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Nova Ves Pod Plesi, Czech Republic
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Pardubice, Czech Republic
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Praha, Czech Republic
France
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Montpellier, France
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Saint Herblain, France
Germany
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Berlin, Germany
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Freiburg, Germany
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Halle, Germany
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Hannover, Germany
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Heidelberg, Germany
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München, Germany
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Stuttgart, Germany
Italy
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Genova, Italy
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La Torretta, Italy
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Milano, Italy
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Napoli, Italy
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Rozzano, Italy
Spain
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A Coruña, Spain
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Barcelona, Spain
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Madrid, Spain
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Valencia, Spain
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Zaragoza, Spain
United Kingdom
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Glasgow, United Kingdom
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Ipswich, United Kingdom
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Maidstone, United Kingdom
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Newcastle-upon-tyne, United Kingdom
Research Site
Sutton, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Jane Robertson	AstraZeneca

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

AstraZeneca Information - Outside of the US 

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00278889 History of Changes
Other Study ID Numbers:	D8480C00041; EUDRACT number 2005-003443-31; HORIZON I
First Posted:	January 19, 2006
Results First Posted:	October 24, 2012
Last Update Posted:	October 24, 2012
Last Verified:	September 2012

Keywords provided by AstraZeneca:

Colorectal Cancer; phase II; metastatic colorectal cancer; AZD2171; RECENTIN

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Bevacizumab; Oxaliplatin; Cediranib	Fluorouracil; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Antineoplastic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Immunosuppressive Agents; Immunologic Factors; Protein Kinase Inhibitors; Enzyme Inhibitors